ClinicalTrials.gg
RecruitingNCT06235216SETHYUpdated Sep 16, 2026

Sacituzumab govitEcan in THYroid Cancers

A Phase 2 interventional study of Sacituzumab govitecan in Differentiated Thyroid Cancer and Anaplastic Thyroid Cancer, sponsored by Grupo Espanol de Tumores Neuroendocrinos. Recruiting at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Grupo Espanol de Tumores Neuroendocrinos · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC).

The main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.

Read the detailed description

The trial will enroll competitively up to 21 patients per cohort. The study will enroll the first 12 patients within the cohort and monitor for response. If no confirmed response is documented the cohort will be closed. If there is one or more confirmed responses reported that cohort will be expanded up to the expected 21 patients. All patients, male or female, ≥ 18 years, with ECOG PS 0-1. Cohort 1 will include patients with advanced radioactive-iodine refractory DTC who progressed to previous TKIs (including but not limited to lenvatinib, sunitinib or cabozantinib) and cohort 2 will include patients with advanced or metastatic ATC who may be on first-line or progressed to a previous systemic treatment. Patients will have not received previously chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that are not completed 2 weeks before first dose of study treatment (See Section 6 for further detail on eligibility).

All enrolled patients will receive sacituzumab govitecan (10 mg/kg intravenously) on Days 1 and 8 of a 21-day cycle. Patients will be treated until progression, death, study withdrawal, or unacceptable toxicity. Sacituzumab govitecan is administered intravenously as a slow infusion as described below.

Dosing is based on the patient's body weight on Day 1 of each cycle (or at each dosing day if change in body weight is >10% or if required by institutional policy). Sacituzumab govitecan at 10 mg/kg will be the highest assigned dose. Dose reductions and delays will be allowed.

All patients will undergo periodic tumor assessments by CT or MRI scan every 12 weeks ± 14 days (3 months), and blood monitoring of tumor markers (i.e. thyroglobulin if applicable) every 12 weeks ± 3 days (3 months) from the start of study treatment until progression or patient withdrawal.

02

Conditions studied

  • Differentiated Thyroid Cancer
  • Anaplastic Thyroid Cancer

Keywords

  • TROP-2
  • sacituzumab govitecan
  • Antibody-drug conjugate
  • SN-38
03

In context

Thyroid Carcinoma, Anaplastic

87 studies on the registry are indexed under Thyroid Carcinoma, Anaplastic; 18 are open to participants now.

This study's planned enrollment of 42 is above the median of 27 across 71 interventional studies indexed under Thyroid Carcinoma, Anaplastic.

Browse Thyroid Carcinoma, Anaplastic studies →

Lead sponsor

Grupo Espanol de Tumores Neuroendocrinos is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written .
  2. Patient is ≥ 18 years of age.
  3. Patient has confirmed or locally advanced unresectable radioactive-iodine differentiated thyroid cancer (cohort A) or anaplastic thyroid carcinoma (cohort B).
  4. Prior therapy in each cohort:

    1. Cohort A: Patients must have experienced progression on at least one previous treatment line with approved systemic therapies (Sorafenib, Lenvatinib or Cabozantinib) and a maximum of 3 prior systemic therapies.
    2. Cohort B: Patients should be included in setting or after failure of any systemic therapy (up to 1 prior treatment lines).
  5. Patient has radiographically documented and measurable metastatic or locally advanced disease at baseline.
  6. An sample should be available for submission to the central laboratory for translational studies. If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided. No central pathological review will be needed to include the patient in the trial.
  7. Patient has (ECOG) performance status of 0 or 1.
  8. The following baseline laboratory data without transfusional support:

    1. (ANC) ≥ 1,500/mm3.
    2. count ≥ 100 × 109/L.
    3. ≥ 9 g/dL.
    4. Serum ≤ 1.5 × (ULN). Note: patients with Gilbert's disease are excluded.
    5. Serum albumin > 3 g/dL.
    6. (CrCl) ≥ 60 mL/min as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection ( can also be used instead of CrCl).
    7. (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 xULN for patients with liver metastases.
  9. Female patients must either:

    1. Be of nonchildbearing potential:

      I) *(defined as at least 1 year without any menses) prior to screening , or II) Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).

      *Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for subjects.

      OR

    2. If of childbearing potential:

    I) Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, II) And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), III) And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration.

  10. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.
  11. Male patients must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.
  12. Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 6 months after the final study drug administration.
  13. Patient agrees not to participate in another interventional study while on treatment in the present study.

Exclusion criteria

Exclusion Criteria:

  1. Patient has central nervous system (CNS) .
  2. Patient has ongoing toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).

    Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

  3. Patient has a history of another within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.

    Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.

  4. Patient has known active or active :

    1. Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
    2. Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.
    3. Patients who test positive for antibody.
  5. Patient has a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
  6. Patient has documented history of a cerebral vascular event (stroke or ), or the following criteria for cardiac disease:

    1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.
    2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of prolongation.
    3. (NYHA) class III or greater congestive heart failure or of \< 40%.
  7. Known history of clinically significant active , or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose of study drug.
  8. Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of gastrointestinal obstruction or perforation within 6 months of enrollment.
  9. Patient has uncontrolled hypertension or diabetes.
  10. Patient has radiotherapy or major surgery within 4 weeks prior to the first dose of study drug.
  11. Patients has received a within 30 days, or antibiotics within one week prior to the first dose of study drug.
  12. Patient has had chemotherapy, biologics, agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to the first dose of study drug.

    Note: Patients participating in observational studies are eligible.

  13. Patient has previously received topoisomerase 1 inhibitors.
  14. Patient has known to sacituzumab govitecan or to any contained in the drug formulation.
  15. Patient has other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.
Terms in these criteria, in plain language(32)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Experimental

    Sacituzumab govitecan (10 mg/kg) administered intravenously on Days 1 and 8 of a 21-day cycle. Patients will be treated until progression, death, study withdrawal, or unacceptable toxicity.

    Drug: Sacituzumab govitecan

Interventions

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period. Objective responses will be assessed locally by the investigator according to RECIST, version 1.1

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

Secondary outcomes

  1. Disease control rate (DCR)

    Percentage/proportion of patients with complete response (CR) or partial response (PR), according to ORR definition for the trial, or maintained stable disease (SD) as their overall best response, assessed by imaging follow-up (CT scan/MRI) and RECIST 1.1 criteria. Stable disease should be maintained for at least 4 months to be considered as a CBR event.

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

  2. Duration of response (DoR)

    Time from first confirmed response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

  3. Progression-free survival (PFS)

    Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

  4. Overall survival (OS)

    Time elapsed from the first dose of study treatment until death from any cause. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patient status at each visit. Long term follow up to be performed at least every 6 months.

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

  5. Safety profile

    Percentage/proportion of patients that experience adverse events classified by their type, severity and seriousness according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0) scoring system.

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

  6. Patient self-reported quality of life (QoL)

    Assessed at baseline and every 12 weeks until progression through the EORTC QLQ-C30 questionnaire. The questionnaire is a validated tool composed of 30 questions or items that assess QoL in relation to physical, emotional, social aspects. The questionnaire is structured in 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), 1 global health status scale, and 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhea and economic impact). Values between 1 and 4 (1: not at all, 2: a little, 3: quite, 4: a lot) are assigned according to the patient's responses to the item, only in items 29 and 30 are they evaluated with a score of 1 to 7 (1: dreadful, 7: excellent). The scores obtained are standardized to 0-100.

    Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient

Other outcomes

  1. TROP-2 positive rate

    Determined centrally on most recent archival tumor samples collected at baseline. Percentage/proportion of patients considered positive for the expression of TROP-2 gene. Strong complete membranous staining in \>5% of cells was considered positive.

    Time frame: Baseline

07

Study locations

9 of 11 sites recruiting
  • Hospital Universitari Vall d&#39;Hebron
    Barcelona, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Complexo Hospitalario Universitario de Ferrol
    Ferrol, Spain
    Not yet recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Institut Catala d´Oncologia (ICO) -Hospitalet
    Hospitalet de Llobregat (Barcelona), Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Hospital Clínico San Carlos
    Madrid, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Desingated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Hospital Universitario la Paz
    Madrid, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Hospital Universitario Ramón y Cajal
    Madrid, Spain
    Not yet recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • MD Anderson Cancer Center Madrid
    Madrid, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A principal investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Hospital General Universitario Morales Meseguer
    Murcia, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Hospital Universitario Central de Asturias
    Oviedo, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • H.U. Marqués de Valdecilla
    Santander, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
  • Hospital Universitario Miguel Servet
    Zaragoza, Spain
    Recruiting
    • A responsible person Designated by the sponsor · Contactinvestigacion@mfar.net · +34 93 434 44 12
    • A Principal Investigator Designated by the sponsor, M.D.; Ph.D. · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided — Provided upon reasonable request. All compiled or single patient data supporting the results will be publicly available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06235216
Lead sponsor
Grupo Espanol de Tumores Neuroendocrinos
Collaborators
MFAR, Gilead Sciences
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Sep 13, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

A responsible person Designated by the Sponsor
Contact
investigacion@mfar.net
+34 93 434 44 12
Alejandro García-Alvarez, M.D.; Ph.D.
study chair · Hospital Universitario Vall d´Hebron
Jaume Capdevila, M.D.; Ph.D.
study chair · Hospital Universitario Vall d´Hebron

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Sacituzumab govitecan

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